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bitop's Ectoin allergy nasal spray reduces symptoms of acute allergic rhinitis in two-week crossover study

bitop AG, a biotech company specializing in the development of Ectoin®-containing medical devices, reports that Ectoin allergy nasal spray has been shown to significantly reduce symptoms of acute allergic rhinitis in a two-week observational, randomized, comparative crossover study with 50 patients suffering from acute allergic rhinitis. Based on this study, bitop performed a clinical trial on eyes drops and nasal spray in humans using an environmental exposure chamber (EEC) model.

12 Jul 2010

Biogen Idec, Swedish Orphan Biovitrum announce advancement of rFVIIIFc into registrational study

Biogen Idec and Swedish Orphan Biovitrum today announced that they plan to advance the companies' long-lasting, fully-recombinant factor VIII Fc fusion protein (rFVIIIFc) into a registrational clinical trial in people with hemophilia A. The decision to advance the program is based on promising data from a Phase 1/2a open-label, cross-over, multi-center, dose-escalation study that evaluated the safety and pharmacokinetics of an intravenous injection of rFVIIIFc in 16 previously-treated patients with severe hemophilia A.

12 Jul 2010

Study results show no improvement in overall survival for combination of gemcitabine and Amplimexon

AmpliMed Corporation, a cancer therapeutics company, today announced results from AMP-019, a randomized double-blind, placebo-controlled Phase II screening trial designed to determine if a Phase III trial was warranted for the combination of gemcitabine (Gemzar, Eli Lilly) plus Amplimexon (AmpliMed Corporation) in patients with advanced pancreatic ductal adenocarcinoma of the pancreas.

12 Jul 2010

Mesoblast schedules formal meeting with FDA to discuss proposed Phase 3 clinical trial program

Australian regenerative medicine company, Mesoblast Limited, today announced that based on positive results from its bone marrow transplant clinical trial conducted at the University of Texas MD Anderson Cancer Center, a formal meeting has been scheduled with the United States Food and Drug Administration to discuss a proposed Phase 3 clinical trial program.

12 Jul 2010

Phase III study results of imiquimod creams for treatment of EGW presented at HPV Conference

Results from a Phase III program evaluating imiquimod 3.75% and 2.5% creams for the treatment of EGW, applied once daily for up to 8 weeks, demonstrated that both were well-tolerated and more efficacious than placebo, according to data presented at the annual Human Papillomavirus Conference in Montreal, July 3 - 8. Investigators found that efficacy was greatest for imiquimod 3.75% with an enhanced safety profile.

9 Jul 2010

Phase II trial results of TB-402 presented at International Congress on Thrombosis

BioInvent International AB and ThromboGenics NV announce that the positive results from a Phase II trial of TB-402 (Anti-Factor VIII antibody) were presented at the 21st International Congress on Thrombosis in Milan, Italy yesterday. TB-402 is a novel, long acting anticoagulant that is being developed as a single injection for the prevention of venous thromboembolism following orthopaedic surgery.

9 Jul 2010

Bayer HealthCare to present BAY86-6150 rFVIIa Phase I clinical data at XXIX WFH International Congress

Phase I clinical data for BAY86-6150, a novel recombinant factor VIIa protein (rFVIIa) being developed by Bayer HealthCare, will be presented at the XXIX International Congress of the World Federation of Hemophilia (WFH) to be held in Buenos Aires, Argentina from Saturday, July 10-Wednesday, July 14.

9 Jul 2010

Rockwell Medical completes End of Phase II meeting with FDA regarding SFP

Rockwell Medical, a fully-integrated biopharmaceutical company offering innovative products and services targeting end-stage renal disease, chronic kidney disease, and iron deficiency anemia, announced today that it has successfully completed an End of Phase II meeting with the U.S. Food and Drug Administration regarding the Company's lead drug candidate Soluble Ferric Pyrophosphate, a novel continuous iron-replacement therapy designed to treat iron deficiency anemia in hemodialysis patients.

8 Jul 2010

Advanced Life Sciences announces positive results from preclinical studies of Restanza IV

Advanced Life Sciences Holdings, Inc., a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, today announced positive results from preclinical toxicology and pharmacokinetic studies of an intravenous (IV) formulation of its novel antibiotic, Restanza™ that support its use in a hospital setting.

8 Jul 2010

Kiadis Pharma receives FDA approval for IND to start pivotal clinical study for ATIR

Biopharmaceutical Company Kiadis Pharma announced today that it has received approval for its Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) to start the pivotal clinical study for its product ATIR™ in the United States. Kiadis Pharma is currently enrolling patients in a multinational, pivotal clinical study at hospitals in Europe and Canada. With the approval of the IND, US hospitals will also participate in this study.

8 Jul 2010

Selvita, Orion collaborate to develop and commercialize SEL103 Alzheimer’s disease program

Selvita sp. z o.o., from Krakow, Poland and Orion Corporation from Espoo, Finland (ORNBV) today announced that they have entered into a global collaboration to jointly develop and commercialize SEL103, Selvita's proprietary program for the treatment of Alzheimer's disease and other cognitive disorders. Selvita will be responsible for early research on the program and Orion will take over the pre-clinical and clinical development as well as further commercialization.

8 Jul 2010

Nymox reports positive new results from pooled analysis of NX-1207 clinical trials for BPH

Nymox Pharmaceutical Corporation reported today positive new results from pooled analysis of completed clinical trials of NX-1207, the Company's investigational drug for BPH. The trial data shows that patients receiving NX-1207 recorded significant quantitative improvement in the important symptom of urgent need to urinate.

8 Jul 2010

GSK, XenoPort disappointed with GSK1838262/XP13512 phase 2b study for migraine headaches

GlaxoSmithKline and XenoPort, Inc. announced today that GSK1838262/XP13512 (gabapentin enacarbil) did not demonstrate a statistically significant improvement compared to placebo as a prophylactic treatment for migraine headaches. This phase 2b dose-ranging study evaluated the efficacy, safety and tolerability of GSK1838262 in adults diagnosed with migraine headache (with or without aura) according to the International Headache Society criteria.

8 Jul 2010

Olaparib shows promising results against inherited forms of breast and ovarian cancer

Olaparib, a new type of experimental drug called a PARP inhibitor, has shown promising results against inherited forms of breast and ovarian cancer in two small clinical trials led by scientists at the Breakthrough Breast Cancer Research Unit at King's College London.

8 Jul 2010

NOXXON to commence multiple ascending dose study of MCP-1 targeting anti-inflammatory Spiegelmer NOX-E36

NOXXON Pharma AG announced today that it has permission to commence a multiple ascending dose study of its Monocyte Chemoattractant Protein-1 (MCP-1) targeting anti-inflammatory Spiegelmer®, NOX-E36. NOXXON plans to develop NOX-E36 for the treatment of diabetic nephropathy and other diabetes related complications.

7 Jul 2010

Neoprobe initiates third multi-center Phase 3 clinical study of Lymphoseek

Neoprobe Corporation, a diversified developer of innovative oncology surgical and diagnostic products, today announced that a third multi-center Phase 3 clinical study of Lymphoseek (NEO3-09) has received investigational review board approval and begun enrollment of subjects diagnosed with breast cancer or melanoma.

7 Jul 2010

Alnylam Pharmaceuticals initiates dosing in Phase I human clinical study with ALN-TTR01

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today it has initiated dosing in a Phase I human clinical study with ALN-TTR01. The study is aimed at evaluating the safety and tolerability of ALN-TTR01 in patients with transthyretin -mediated amyloidosis, and is also designed to provide preliminary data on human proof of concept based on measurements of TTR serum levels.

7 Jul 2010

Nile completes dosing in CD-NP Phase II study for acute decompensated heart failure

Nile Therapeutics, Inc., a biopharmaceutical company focused on the development of novel therapeutics for cardiovascular disease, today announced that it has completed the dosing of the last patient in NIL-CDNP-CT005, an open-label, single-blind, placebo-controlled Phase II study of CD-NP in patients with acute decompensated heart failure, or ADHF. The study was designed to provide additional information on the safety and tolerability of CD-NP when infused for up to 72 hours in patients with ADHF and mild to moderate renal insufficiency.

7 Jul 2010

Data on activity of Nektar's NKTR-102 in gastrointestinal cancer presented at ESMO 12th World Congress

Nektar Therapeutics announced today that data presented at the European Society for Medical Oncology (ESMO) 12th World Congress on Gastrointestinal Cancer demonstrates that NKTR-102, the company's lead oncology compound, exhibits superior activity compared to irinotecan as part of either a monotherapy or combination regimen in tumor models of gastrointestinal cancers.

7 Jul 2010

Combination of Biothera's Imprime PGG and Erbitux doubles response rate in colorectal cancer patients

The combination of Biothera's experimental drug Imprime PGG® and Erbitux® (cetuximab) doubled the historical overall response rate and the time to progression of second- and third-line metastatic colorectal cancer patients treated with Erbitux monotherapy. The data was released last weekend at the 13th World Congress on Gastrointestinal Cancer at the European Society for Medical Oncology (ESMO).

7 Jul 2010

Drug Trial News

bitop's Ectoin allergy nasal spray reduces symptoms of acute allergic rhinitis in two-week crossover study

Biogen Idec, Swedish Orphan Biovitrum announce advancement of rFVIIIFc into registrational study

Study results show no improvement in overall survival for combination of gemcitabine and Amplimexon

Mesoblast schedules formal meeting with FDA to discuss proposed Phase 3 clinical trial program

Phase III study results of imiquimod creams for treatment of EGW presented at HPV Conference

Phase II trial results of TB-402 presented at International Congress on Thrombosis

Bayer HealthCare to present BAY86-6150 rFVIIa Phase I clinical data at XXIX WFH International Congress

Rockwell Medical completes End of Phase II meeting with FDA regarding SFP

Advanced Life Sciences announces positive results from preclinical studies of Restanza IV

Kiadis Pharma receives FDA approval for IND to start pivotal clinical study for ATIR

Selvita, Orion collaborate to develop and commercialize SEL103 Alzheimer’s disease program

Nymox reports positive new results from pooled analysis of NX-1207 clinical trials for BPH

GSK, XenoPort disappointed with GSK1838262/XP13512 phase 2b study for migraine headaches

Olaparib shows promising results against inherited forms of breast and ovarian cancer

NOXXON to commence multiple ascending dose study of MCP-1 targeting anti-inflammatory Spiegelmer NOX-E36

Neoprobe initiates third multi-center Phase 3 clinical study of Lymphoseek

Alnylam Pharmaceuticals initiates dosing in Phase I human clinical study with ALN-TTR01

Nile completes dosing in CD-NP Phase II study for acute decompensated heart failure

Data on activity of Nektar's NKTR-102 in gastrointestinal cancer presented at ESMO 12th World Congress

Combination of Biothera's Imprime PGG and Erbitux doubles response rate in colorectal cancer patients

Advancing Motor Neuron Disease Diagnosis with Non-Invasive Ultrasound and AI

How agentic AI is reshaping laboratory workflows

Fourier 80: bringing benchtop NMR systems to the laboratory

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